bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA device recall Z-0440-2026 · posted 2025-11-06 · Open, Classified
Recall details
- Recalling firm
- B-K Medical A/S
- Reason for recall
- GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
- Action taken
- GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION NOTICE" to its consignees on 10/09/2025 via traceable means. The notice explained the issue, potential risk, and requested: "Actions to be taken by Customer / User You can continue to use your device by following the instructions below: 1. Review and follow the applicable addendums to the Instructions for Use and the updated Service Manuals. The Addendums and Service Manuals are available for download at: https://www.gehealthcare.com/support/manuals. 2. Follow the conditions defined within the addendum and Service Manual applicable to your product for further instructions. 3. Place the applicable addendum and Service Manual with your existing product Instructions for Use. 4. If you have difficulty accessing the documentation or require a printed copy of the applicable addendum or Service Manual, please contact a GE HealthCare Service Representative for assistance. Please ensure all potential users in your facility are made aware of this safety notification and the required actions. Please retain this document for your records." For questions or concerns regarding this notification, please contact GE HealthCare at 1-800-645-4442 or bksupport.us@gehealthcare.com or your local Service Representative.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IYN
- Quantity affected
- 895 units
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech
- Date initiated
- 2025-10-09
- Date posted
- 2025-11-06
- Location
- Herlev, Denmark
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ultrasound System 2300 (K223830) | Bk Medical Aps | 2023-04-11 |